We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase II Study of a Continuous Hepatic Arterial Infusion Combination Therapy With OPC-18 and 5-FU in Patients With Highly Advanced Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00524498
Recruitment Status : Completed
First Posted : September 3, 2007
Last Update Posted : October 15, 2015
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of a continuous hepatic arterial infusion combination therapy with OPC-18 and 5-FU versus BST in patients with highly advanced hepatocellular carcinoma for which resection therapy or local therapy is inapplicable due to advanced vascular invasion.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: OPC-18 Drug: cisplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of a Continuous Hepatic Arterial Infusion Combination Therapy With OPC-18 and 5-FU in Patients With Highly Advanced Hepatocellular Carcinoma
Study Start Date : September 2007
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
FAIT
Drug: OPC-18
OPC-18: 500IU * 3 times a week, sc 5-FU : 500mg infusion for 5days into hepatic artery
Active Comparator: B
BST
Drug: cisplatin
infusion into hepatic artery with cisplatin 10mg and 5-FU 250mg a day
Other Name: low-dose FP treatment



Primary Outcome Measures :
  1. Antitumor effect (tumor size reduction) [ Time Frame: every 4 weeks ]

Secondary Outcome Measures :
  1. Disease control rate Overall survival Progression-free survival [ Time Frame: every 4 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are histologically or clinically (diagnostic imaging and tumor marker) diagnosed with hepatocellular carcinoma
  • Patients with a measurable lesion by contrast CT
  • Patients with no remote metastasis (extrahepatic metastasis), confirmed by X-ray, CT, MRI, or other means if necessary
  • Patients who have not previously received intra-arterial hepatic chemotherapy

Exclusion Criteria:

  • Patients receiving the herbal medicine shosaikoto
  • Patients with autoimmune hepatitis
  • Patients with a history of hypersensitivity to OPC-18 or other interferon preparations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00524498


Locations
Japan
Chubu region, Japan
Chugoku region, Japan
Hokkaido region, Japan
Kanto region, Japan
Kinki region, Japan
Kyushu region, Japan
Tohoku region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Katsuhisa Saito Divsion of New Product Development

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00524498     History of Changes
Other Study ID Numbers: 018-06-002
First Posted: September 3, 2007    Key Record Dates
Last Update Posted: October 15, 2015
Last Verified: October 2015

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
OPC-18
Interferon-alpha
Fluorouracil

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Cisplatin
Antineoplastic Agents